Quality Assurance of Immunological Laboratory Determinants
The Immunology Virology Quality Assessment Center (IVQAC) is led by Thomas N. Denny. The IVQAC is a resource designed to help domestic and international immunologists evaluate and enhance the integrity and comparability of immunological laboratory determinations performed on patients enrolled in multi-site HIV/AIDS therapeutic, vaccine and prevention investigations. The IVQAC has multiple focuses including directing the External Quality Assurance Program Oversight Laboratory (EQAPOL) and the Immune Quality Assessment (IQA) program, which focuses on quality assurance for Peripheral Blood Mononuclear Cells (PBMCs) and the development and quality assurance of Flow Cytometry and Immune Function Assays. Additionally, the IVQAC has an international unit that focuses on developing new alternative approaches to measuring CD4 cell levels in resource limited areas. This unit also focuses on developing QC/QA programs for clinical trials and capacity building for developing laboratories or staff in resource-limited areas. The IVQAC is also collaborating with Georgia Tomaras and Advanced Liquid Logic (ALL), to continue the development of a rapid, point-of-care HIV-1 diagnostic device. Finally, the IVQAC offers both the Clinical Flow Cytometry Shared Resource and the Non-human Primate Viral Load Testing Shared Resource to DHVI investigators and the Duke community.
In September 2010, the IVQAC was awarded funding from the National Institute of Allergy and Infectious Diseases (NIAID) to establish EQAPOL, which encompasses multiple areas of research critical to HIV vaccine discovery and clinical trials. EQAPOL is comprised of seven main programs: maintain and expand a PBMC bank and EQA reagent repository, establish a PBMC EQA Program, implement an Enzyme-linked immunosorbent spot (ELISpot) EQA Program, implement an EQA program for Flow Cytometry-based assays, establish and characterize unique clade-specific HIV virus panels, implement a Luminex EQA program and create a central web-based application and database for the listed activities. The IVQAC maintains the PBMC bank and reagent repository, runs the PBMC EQA program, and is responsible for many aspects of the viral diversity program. Finally, the IVQAC oversees the management of the program, working with the other EQAPOL leaders, Kent J. Weinhold, Guido Ferarri and Greg Sempowski, to ensure the successful completion of EQAPOL aims.
In October 2007, the IVQAC received funding from NIAID to expand its efforts to standardize and improve the quality of CD4 testing across domestic and international laboratories funded by the NIAID, the Centers for Disease Control (CDC) and many other organizations. The IVQAC is currently working with 73 labs in the U.S. and 55 labs across 28 other countries in Africa, Latin America, South America and the Caribbean.
PBMC Quality Assurance Program
In January 2008, the IVQAC received funding from the National Institutes of Health (NIH) to establish the PBMC Quality Assurance Program. This program offers proficiency testing of PBMC cryopreservation at sites funded by NIAID and currently has 91 laboratories enrolled. As part of the PBMC QA program, the IVQAC team develops sensitive functional and phenotypic assays to monitor the quality of frozen PBMCs including cell recovery, cell viability, and biological function. The IVQAC team provides Quality Control (QC) mechanisms to assess the ability of sites to process, freeze, store and ship viable PBMCs for future use. As part of this initiative, the IVQAC established the DHVI Data Management Center, which provides statistical analysis of QC results. Additionally, the IVQAC maintains a PBMC cell bank harvested from donors participating in the ongoing CHAVI leukapheresis program.
Advanced Liquid Logics Point-of-care Device
The IVQAC is working to develop a device that is designed for use in resource-limited settings, to provide rapid sample-to-answer capability from a fingerstick whole blood input. Work in the past year focused on assay development and proof-of concept for both a diagnostic HIV-1 RNA test and an HIV-1 EIA, in addition to improvements in instrument design (reduced power consumption, device footprint, and reagent storage capabilities). The first annual Scientific Advisory Board meeting was held in December 2010 and provided excellent feedback from NIAID and an advisory panel with experience in diagnostic development and HIV-1 related global health issues. Current efforts are focused on integrating sample preparation methods with PCR and EIA capabilities, finalizing a prototype device and initiating beta testing of the device on clinical samples in late 2011.
In July 2008, the IVQAC was awarded an accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists (CAP). The IVQAC is one of the more than 6,000 CAP-accredited laboratories nationwide. The CAP Laboratory Accreditation Program, which started in the early 1960s, is recognized by the federal government as being equal to or more stringent than the government's own inspection program. During the CAP accreditation process, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. CAP inspectors also examine the entire staff's qualifications, the laboratory's equipment, facilities, safety program and record, as well as the overall management of the laboratory.
CRI Immune Proficiency Panel Program
Finally, the IVQAC recently received funding from the Cancer Research Institute to serve as a central processing laboratory for the Cancer Vaccine Consortium's Immune Proficiency Panel Program.
For the IVQAC website, please visit: http://iqa.center.duke.edu
For the EQAPOL website, please visit: http://eqapol.dhvi.duke.edu